An observational study in Integrated Assessment, Immune-Inflammatory and Metabolic Biomarkers, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Sohag University · Observational
This study aims to evaluate the combined predictive value of immune-inflammatory and metabolic biomarkers for coronary no-reflow following primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI), with the goal of improving early risk stratification and clinical decision-making.
ST-segment elevation myocardial infarction (STEMI) remains one of the leading causes of morbidity and mortality worldwide, accounting for a substantial proportion of deaths related to ischemic heart disease.
Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy for STEMI, as it restores epicardial coronary blood flow and significantly reduces mortality compared with thrombolytic therapy.
In recent years, composite immune-inflammatory indices such as the Systemic Immune-Inflammation Index (SII) have emerged as simple and reproducible markers reflecting the balance between inflammation and immune response. In parallel, metabolic indices such as the Triglyceride-Glucose (TyG) index and the uric acid-to-HDL cholesterol ratio (UHR) have been proposed as surrogate markers of insulin resistance, oxidative stress, and endothelial dysfunction-all of which contribute to microvascular injury.
688 studies on the registry are indexed under ST Elevation Myocardial Infarction; 184 are open to participants now.
This study's planned enrollment of 400 is above the median of 335 across 229 observational studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →Sohag University is the lead sponsor of 1,218 studies on the registry; 627 are open to participants now.
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This prospective multi-center observational cohort study will be conducted in the Cardiology Department on 400 patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI)
Diagnostic Test: Assessment of immune-inflammatory and metabolic biomarkers
Venous blood samples will be collected on admission before primary percutaneous coronary intervention for complete blood count and biochemical analysis. Laboratory results will be used to calculate the Systemic Immune-Inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), Systemic Inflammatory Response Index (SIRI), Triglyceride-Glucose (TyG) index, and uric acid-to-HDL cholesterol ratio (UHR).
Predictive performance of the Systemic Immune-Inflammation Index (SII) for coronary no-reflow
Predictive performance of admission Systemic Immune-Inflammation Index (SII), calculated as platelet count × neutrophil count / lymphocyte count, for coronary no-reflow following primary percutaneous coronary intervention (PCI), assessed using the area under the receiver operating characteristic (ROC) curve.
Time frame: During the primary percutaneous coronary intervention (Day 1).
Occurrence of coronary no-reflow following primary percutaneous coronary intervention
Percentage of participants with coronary no-reflow, defined as final thrombolysis in myocardial infarction (TIMI) flow grade \<3 and/or myocardial blush grade ≤1 at the end of primary percutaneous coronary intervention (PCI), in the absence of mechanical obstruction such as dissection, residual stenosis, or spasm.
Time frame: Day 1, immediately at the end of primary percutaneous coronary intervention
Predictive performance of the Triglyceride-Glucose index for coronary no-reflow
Area under the receiver operating characteristic (ROC) curve for admission triglyceride-glucose (TyG) index in predicting coronary no-reflow following primary percutaneous coronary intervention (PCI). TyG is calculated as ln \[triglycerides (mg/dL) × fasting glucose (mg/dL) / 2\]
Time frame: Day 1, at the end of percutaneous coronary intervention
Predictive performance of the uric acid-to-HDL cholesterol ratio (UHR) for coronary no-reflow
Area under the ROC curve for admission uric acid-to-HDL cholesterol ratio (UHR) in predicting coronary no-reflow following primary percutaneous coronary intervention (PCI). UHR is calculated as serum uric acid divided by HDL cholesterol.
Time frame: Day 1, at the end of percutaneous coronary intervention
Occurrence of in-hospital heart failure
ercentage of participants who develop heart failure during the index hospitalization. Its association with admission immune-inflammatory and metabolic biomarkers will be evaluated.
Time frame: Until discharge or death during the index hospitalization (up to 30 days)
Occurrence of in-hospital malignant arrhythmias
Percentage of participants who experience malignant arrhythmias during the index hospitalization. Their association with admission immune-inflammatory and metabolic biomarkers will be evaluated.
Time frame: Until discharge or death during the index hospitalization (up to 30 days)
Occurrence of in-hospital cardiogenic shock
Percentage of participants who develop cardiogenic shock during the index hospitalization. Its association with admission immune-inflammatory and metabolic biomarkers will be evaluated.
Time frame: Until discharge or death during the index hospitalization (up to 30 days)
Occurrence of in-hospital reinfarction
Percentage of participants who experience reinfarction during the index hospitalization. Its association with admission immune-inflammatory and metabolic biomarkers will be evaluated.
Time frame: Until discharge or death during the index hospitalization (up to 30 days)
All-cause in-hospital mortality
Percentage of participants who die from any cause during the index hospitalization. Its association with admission immune-inflammatory and metabolic biomarkers will be evaluated.
Time frame: Until discharge or death during the index hospitalization (up to 30 days)
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
Time frame: After the end of study for one year.
Access criteria: The data will be available upon a reasonable request from the corresponding author.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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